Trial Outcomes & Findings for Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective) (NCT NCT05753891)
NCT ID: NCT05753891
Last Updated: 2026-04-17
Results Overview
Pinch Strength measurements
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
6 months post procedure
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.
Suture Tape Reconstruction: This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.
|
Carpometacarpal (CMC) Standard Ligament Reconstruction
Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)
Baseline characteristics by cohort
| Measure |
Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
n=17 Participants
Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.
Suture Tape Reconstruction: This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.
|
Carpometacarpal (CMC) Standard Ligament Reconstruction
n=5 Participants
Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
4 Participants
n=130 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=130 Participants
|
5 Participants
n=132 Participants
|
18 Participants
n=130 Participants
|
|
Age, Continuous
|
66.2 Years
STANDARD_DEVIATION 9.1 • n=130 Participants
|
72.6 Years
STANDARD_DEVIATION 7.8 • n=132 Participants
|
67.7 Years
STANDARD_DEVIATION 9.1 • n=130 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=130 Participants
|
5 Participants
n=132 Participants
|
16 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
6 Participants
n=130 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=130 Participants
|
5 Participants
n=132 Participants
|
20 Participants
n=130 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=130 Participants
|
5 participants
n=132 Participants
|
22 participants
n=130 Participants
|
PRIMARY outcome
Timeframe: 6 months post procedurePopulation: Pinch strength was measured using a dynamometer (kg force), with higher values indicating greater strength. Due to early study termination, most participants did not reach the 6-month follow-up. No participants in the CMC suture tape group and only 2 in the standard group were evaluable. Data are limited and reported descriptively; no statistical comparisons were performed due to small sample size.
Pinch Strength measurements
Outcome measures
| Measure |
Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.
Suture Tape Reconstruction: This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.
|
Carpometacarpal (CMC) Standard Ligament Reconstruction
n=2 Participants
Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.
|
|---|---|---|
|
Pinch Strength
|
—
|
10 lbs
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 6 months post procedurePopulation: PROMIS-UE scores were intended to be collected at pre-specified follow-up intervals. Due to early study termination, most participants did not reach the 6-month timepoint. No participants in the CMC Suture Tape group and only 2 participants in the CMC Standard group were evaluable at 6 months. Available data are reported descriptively. No formal statistical analysis was conducted due to the limited sample size.
PROMIS-UE scores are reported as T-scores standardized to the U.S. population (mean 50, SD 10; typical range \~15-61). Higher scores indicate better upper extremity function.
Outcome measures
| Measure |
Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.
Suture Tape Reconstruction: This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.
|
Carpometacarpal (CMC) Standard Ligament Reconstruction
n=2 Participants
Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.
|
|---|---|---|
|
PROMIS-UE
|
—
|
36.5 t-score
Standard Deviation 7.8
|
Adverse Events
Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Carpometacarpal (CMC) Standard Ligament Reconstruction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place